Phase 2/3, Multistage, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Group Withdrawal Study to Evaluate the Efficacy and Safety of Nipocalimab Administered to Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Status: Recruiting
Location: See all (92) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

The main purpose of this study is to evaluate the safety and efficacy of nipocalimab compared to placebo in delaying relapse in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) who initially respond to nipocalimab in Stage A.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults greater than or equal to (\>=) 18 years of age at the time of consent and as applicable, must also meet the legal age of consent in the jurisdiction in which the study is taking place

• Diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) according to criteria of the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) 2021, progressing or relapsing forms. CIDP diagnosis to be adjudicated by independent committee during screening period

• Inflammatory Neuropathy Cause and Treatment (INCAT) disability score between 2 and 9 at the Run-In Baseline visit for participants entering Run-In, or Stage A Baseline visit for participants directly entering Stage A. Participants with an INCAT score of 2 at trial entry must have this score exclusively from the leg disability score

• Fulfilling any of the following treatment conditions: a) Currently treated with oral corticosteroids (CS) less than or equal to (\<=) 20 milligrams (mg)/day; or b) Currently treated with pulsed CS, and/or intravenous immunoglobulin (IVIg) or subcutaneous immunoglobulin (SCIg) and the participant is willing to discontinue no later than the run-in baseline visit; or c) Currently treated with oral CS greater than (\>) 20 mg/day and the participant is willing to taper to \<=20 mg/day during the run-in period; or d) Without previous treatment (treatment naive); or treatment with CS and/or IVIg or SCIg discontinued at least 3 months prior to screening (untreated)

• Active disease as determined by CIDP Disease Activity Status (CDAS) score \>= 3

• Other protocol-defined inclusion criteria will apply

Locations
United States
Colorado
IMMUNOe Health and Research Centers
RECRUITING
Centennial
Florida
Neurology Associates PA
COMPLETED
Maitland
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Massachusetts
Boston Clinical Trials
RECRUITING
Boston
Maryland
Johns Hopkins Hospital
RECRUITING
Baltimore
Michigan
Beaumont Hospital Royal Oak
COMPLETED
Royal Oak
North Carolina
The Neurological Institute, PA
RECRUITING
Charlotte
New York
The Neurological Institute of New York
COMPLETED
New York
South Shore Neurologic Associates - Patchogue
RECRUITING
Patchogue
Ohio
Cleveland Clinic Main Campus
RECRUITING
Cleveland
Texas
Austin Neuromuscular Center
RECRUITING
Austin
Wisconsin
Advocate Health - Aurora St. Luke's Medical Center
RECRUITING
Milwaukee
Other Locations
Australia
The Alfred Hospital
RECRUITING
Melbourne
Gold Coast University Hospital
RECRUITING
Parkwood
China
Beijing Tiantan Hospital, Capital Medical University
RECRUITING
Beijing
Peking University First Hospital
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
Xuanwu Hospital ,Capital Medical University
RECRUITING
Beijing
The First Hospital of Jilin University
RECRUITING
Changchun
The Third Xiangya Hospital of Central Sourth University
RECRUITING
Changsha
Xiangya Hospital Central South University
RECRUITING
Changsha
Chifeng Municipal Hospital
RECRUITING
Chifeng
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
The First Affiliated Hospital Sun Yat sen University
RECRUITING
Guangzhou
Qianfoshan hospital of Shandong Province
RECRUITING
Jinan
The First Affiliated Hospital of NanChang University
RECRUITING
Nanchang
Huashan Hospital Fudan University
RECRUITING
Shanghai
Tong Ren Hospital Shanghai Jiao Tong University school of medicine
COMPLETED
Shanghai
Xi 'an GaoXin Hospital
RECRUITING
Xi'an
Colombia
Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca
RECRUITING
Floridablanca
Instituto Neurológico de Colombia
RECRUITING
Medellín
France
CHU Bordeaux
RECRUITING
Bordeaux
Hospices Civils de Lyon HCL
RECRUITING
Bron
Hopital de Bicetre
RECRUITING
Le Kremlin-bicêtre
Hopital PASTEUR
RECRUITING
Nice
Hopital de la Pitie Salpetriere
RECRUITING
Paris
CHRU Strasbourg
RECRUITING
Strasbourg
Germany
Judisches Krankenhaus Berlin
RECRUITING
Berlin
St. Josef-Hospital, Ruhr-Universität Bochum
RECRUITING
Bochum
Medizinische Hochschule Hannover
RECRUITING
Hanover
Universitaetsklinikum Leipzig
RECRUITING
Leipzig
St Josefs Krankenhaus Potsdam Sanssouci
RECRUITING
Potsdam
Greece
Attikon General Hospital of Athens
RECRUITING
Athens
Patras University Hospital
COMPLETED
Pátrai
Papageorgiou General Hospital Of Thessaloniki
RECRUITING
Thessaloniki
Italy
Azienda Ospedaliera di Rilievo Nazionale A Cardarelli
RECRUITING
Naples
IRCCS Istituto Clinico Humanitas
RECRUITING
Rozzano
Japan
National Hospital Organization Asahikawa Medical Center
RECRUITING
Asahikawa
Institute of Science Tokyo Hospital
RECRUITING
Bunkyō City
Chiba University Hospital
RECRUITING
Chiba
Seirei Hamamatsu General Hospital
RECRUITING
Hamamatsu
Tokai University Hospital
RECRUITING
Isehara
Kobe City Medical Center General Hospital
COMPLETED
Kobe
National Center of Neurology and Psychiatry
RECRUITING
Kodaira-shi
Saitama Medical Center
RECRUITING
Koshigaya
Kumamoto University Hospital
RECRUITING
Kumamoto
Chubu Rosai Hospital
RECRUITING
Nagoya
Nagoya University Hospital
RECRUITING
Nagoya
Kindai University Hospital
RECRUITING
Osaka Sayama Shi
National Hospital Organization Sendai Medical Center
RECRUITING
Sendai
Dokkyo Medical University Hospital
RECRUITING
Shimotsuga Gun
Tokyo Women's Medical University Hospital
COMPLETED
Shinjuku-ku
Tenri Hospital
RECRUITING
Tenri
Ehime University Hospital
RECRUITING
Toon-shi
Toyama University Hospital
RECRUITING
Toyama
Yamaguchi University Hospital
RECRUITING
Ube
Mexico
i Can Oncology Center
SUSPENDED
Monterrey
Clinical Research Institute S.C.
SUSPENDED
Tlalnepantla
Poland
Centrum Medyczne
COMPLETED
Chorzów
Specjalistyczne Gabinety Lekarskie
COMPLETED
Krakow
Prywatny Gabinet Lekarski
RECRUITING
Lublin
Clinical Research Center sp z o o MEDIC R s k
RECRUITING
Poznan
Portugal
Hospital Garcia de Orta
RECRUITING
Almada
Hospital de Braga
RECRUITING
Braga
Centro Hospitalar de Sao Joao Epe
RECRUITING
Porto
Republic of Korea
Konkuk University Medical Center
COMPLETED
Seoul
Kyunghee University Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Spain
Hosp. Gral. Univ. de Alicante
RECRUITING
Alicante
Hosp Univ Vall D Hebron
RECRUITING
Barcelona
Hosp. Univ. de Basurto
RECRUITING
Bilbao
Hosp. Univ. Donostia
RECRUITING
Donostia / San Sebastian
Hosp. Clinico San Carlos
RECRUITING
Madrid
Hosp. Virgen Macarena
RECRUITING
Seville
Taiwan
Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
National Taiwan University Hospital
RECRUITING
Taipei
Shin Kong Wu Ho Su Memorial Hospital
RECRUITING
Taipei
United Kingdom
University Hospitals Birmingham NHS Foundation Trust
RECRUITING
Birmingham
Royal Devon & Exeter Hospital
RECRUITING
Devon
NHS Greater Glasgow and Clyde
RECRUITING
Glasgow
Royal Free Hospital
RECRUITING
London
Sheffield Teaching Hospitals NHS Foundation Trust
RECRUITING
Sheffield
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2022-09-23
Estimated Completion Date: 2028-09-30
Participants
Target number of participants: 201
Treatments
Experimental: Nipocalimab
Participants in Stage A (Open-label) will receive a loading dose of nipocalimab (Dose 1) intravenous (IV) infusion on Day 1, followed by nipocalimab (Dose 2) IV infusion once every 2 weeks (q2w) from Week 2 to Week 12. Participants who demonstrate evidence of clinical improvement in Stage A (responders) will enter Stage B (Double-blind) and receive nipocalimab (Dose 2) IV infusion q2w starting on Day 1 up to Week 52. After completion of Stage B or discontinuation from Stage B due to relapse, participants will have the option to enter the open label extension (OLE) phase and receive nipocalimab (Dose 2) IV infusion q2w starting on OLE Day 1 until 2 years after marketing authorization in a participant's local country or until nipocalimab becomes available commercially or via other continued access program, whichever comes first.
Placebo_comparator: Placebo
Participants receiving nipocalimab in Stage A and who demonstrate evidence of clinical improvement in Stage A (responders) will enter Stage B (Double-blind) and receive placebo IV infusion q2w starting on Day 1 up to Week 52. After completion of Stage B or discontinuation from Stage B due to relapse, participants will have the option to enter the open label extension (OLE) phase and receive nipocalimab (Dose 2) IV infusion q2w starting on OLE Day 1 until 2 years after marketing authorization in a participant's local country or until nipocalimab becomes available commercially or via other continued access program, whichever comes first.
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov